1. Field of the Invention
This invention relates to tracking and monitoring information, and specifically to an improved system, method, and computer-readable instructions for tracking and monitoring vaccine and pharmaceutical information including data storage and environment sensing.
2. Discussion of the Background
It is known that vaccines are sensitive to both excessive heat and excessive cold. Therefore, it is important that vaccines and other drugs be transported and stored correctly. Careful attention is needed in handling practices from the source to the end-user at the health facility. This can only be achieved by appropriate environmental monitoring. The CDC recommends that information regarding the storage temperatures is to be recorded at least twice a day in a temperature log. However, without continuous monitoring, there remains a possibility that the temperature exceeded a specific threshold for a vaccine/drug.
Moreover, all vaccines and diluents have expiration dates. Expiration dates vary by the type of vaccine or diluent, and by the lot number. Failure to monitor the elapsed time may also lead to expiry of vaccines during storage. The expiration date printed on each vial or box assumes the vaccine has been properly transported and stored at all times and that it has not become contaminated.
During transport, the temperature of vaccines may be monitored by cold chain monitors (CCMs). There are generally three types: those that indicate whether packages have reached temperatures that are too warm, those that indicate whether packages have reached temperatures that are too cold, and those that continuously record the temperature. These types of monitors are designed to be irreversible indicators of inappropriate temperatures. CCMs are not a substitute for twice-a-day temperature reading and recording. Every vaccine storage unit compartment should have its own certified calibrated thermometer for this purpose.
Digital data loggers (DDLs) are miniature, battery-operated, electronic devices that may be programmed to record temperatures at intervals throughout the day. Data loggers are capable of recording hundreds or even thousands of individual temperature readings. Digital data loggers used in vaccine transport have external lights that alert the user to out-of-range temperature events-a green light indicating the cold chain was properly maintained and a red light indicating inappropriate temperature exposure occurred. If a red light is displayed, the vaccine shipment must await approval for use and the device must be sent back to the manufacturer to interpret the temperature data. A special software program must be used to download the temperature data to a computer. Digital data loggers may also be used in vaccine storage units.
However, even with the use of CCMs and DDLs with vaccine shipments and storage units, there is still a possibility that an individual vial or container may have been mistakenly left out of the storage unit for a longer period of time than is acceptable, resulting in damage to the vaccine/drug. Therefore, there is a need in the art for individual monitoring of each vial or container to ensure proper handling and storage. There is also a need in the art for a simple means to retrieve and store this data.
Inventory accounting is also an important factor in vaccine quality management. Proper management includes knowing quantities received, current stock, expiration dates, excess supplies, and inventory needed to be reordered. Stock records may be kept in either computerized or written formats. Some state or local health department immunization programs have developed tally sheets or other vaccine inventory protocols and procedures for vaccine providers. Therefore, inventory management is often a time consuming process. There is a need in the art for a more simplified procedure for tracking inventory.
For example, if a patient qualifies for a government funded vaccine program called Vaccines for Children (VFC), the nurse has to manually register the immunization on a tally sheet. The tally sheets for VFC keep track (for that program) of: vaccines on hand, number of each type of vaccine given, vaccines received during the month, vaccines wasted and number of vaccines left at the end of the month. During certain months, the VFC program also requires (in addition to the normal tally sheet) that for each pt, the nurse manually writes down: every pt that received a VFC vaccine, the patients (pt) date of birth (DOB), what the pt received, and which dose. Also once a year the VFC program “audits” the private office and the nurse is required to present at least 50 immunization records of pts that have the DOBs between the requested dates. During these ‘audits’ the VFC program checks the refrigerator and freezer temperature logs for the entire year. The requirement is that the facility carrying VFC vaccine must check their storage temperatures twice a day, for every day that the practice is open and record this information.
When vaccines are administered, most vaccines are also charted in an electronic medical record (EMR) for the patient. The fact that nurses are using computers to chart these injections minimally increases the speed and accuracy. For example, in current systems, nurses can click on the type of vaccine, but then have to manually enter: lot number, expiration date, route of administration, site, manufacturer and when it was given. There is a need in the art for a more simplified process of recording this information.
Another chart that it required is the Vaccine Information Sheet date (VIS). This is charted to indicate that the parent was told about the VIS. It is the parents' choice to take or refuse the VIS, but the nurse must chart that they have the sheet available for each and every vaccine that is carried in the office.
In addition to computer and paper charting, nurses are required to keep current on all state and federal requirements and standards for immunization schedules, ensuring that all pts are kept up-to-date on all their immunizations.
Once the nurse has ensured that the patient needs vaccines, charts the vaccines in all the appropriate places and gives the vaccines, governing agency request that you share that information with them, each and every time.
The City and County Health Department (CCHD) is one such governing agency. After every vaccine is given, the CCHD requests that the private practice send them: the pts name, pts DOB and what was administered and on what date. The CCHD, in turn, enters this into their database so that healthcare professionals throughout the state, can access that pt's immunization records.
With all the charting, inventory, temperature records, schedules, sharing of information and everything else required to give a patient an immunization and record it, there are obviously multiple opportunities for errors and wasted time.
Accordingly, there is a need in the art for a system that will reduce the time in charting and improve accuracy. There is also a need for a system that assists in inventory and tracking of vaccine and pharmaceutical information.
A number of patents exist that describe various types of tracking and inventory methods, such as U.S. Pat. Nos. 7,370,797, 7,261,235, US20070150312A1, 7,182,259, 7,102,526, US20060106645A1, US20060015536A1, US20050283259A1, US20030160698A1, 6,611,806, US20030055685A1, US20020072991A1, 6,021,392, 5,667,303, and international application No. WO03087996A2 all incorporated herein by reference. No admission is made that any or all of these references are prior art and indeed, it is contemplated that they may not be available as prior art when interpreting 35 U.S.C. 102 in consideration of the claims of the present application.